Lucas

Quality Systems Engineer

Fspg Hi • Tiempo completo

Jul 2023 - Apr 2026 • 2 yrs 9 mos

I spent years on the factory side of Chinese manufacturing — plastic film and flexible packaging for food-contact and medical device applications. My job was to make sure the goods matched the spec, and to answer a customer's auditor's hard questions. You have the same questions now. Here is what I learned answering them. "ARE THEY ACTUALLY A FACTORY, OR A TRADER?" I wrote the shop-floor documentation myself — 47 SOPs and 152 record forms in Chinese, English and Thai. So I know what a real factory's records look like when they are live, and what they look like when they were written the week before you arrived. When a supplier sends you a batch record, I can tell you which one you are holding. "ARE THE CERTIFICATES REAL?" I took a new plant in Thailand through ISO 9001, ISO 13485 and FDA product certification on the first attempt, plus local TFDA and customs audits, and passed ISO 14001, ISO 45001, GRS and Bluesign certification elsewhere. I know which certificates a factory can legitimately claim for which process — and which are a valid certificate for the wrong thing. "WILL THE GOODS MATCH THE SAMPLE?" I led OQ and PQ validation and ran 132 hours of pre-shift training for the new plant's QA and production teams — IQC, IPQC, OQC, calibration, environment. Then I built a defect tracking mechanism that lifted first-pass yield from 94.56% to a stable 98.23%. I have seen every way a production run drifts from the approved sample. "WHO DO I HOLD RESPONSIBLE?" I ran on-site quality audits at 4 core suppliers, and hosted 6 customer factory inspections from the factory side — 100% pass rate. I know what a factory prepares before a buyer arrives, and what it hides. "WHAT HAPPENS WHEN SOMETHING GOES WRONG?" I closed 37 special internal audit findings at 100% and tracked 384 in-process findings to 95.3% closure using 8D and CAPA. When a supplier says they "fixed it", I know the difference between a corrective action and a sentence in an email.

Quality Systems Intern

广州酒家集团股份有限公司 • Tiempo completo

Feb 2023 - Jun 2023 • 4 mos

Where I first saw audits from the inside, at a large food manufacturer. Short placement, but this is where the habits come from. "HOW DOES A SUPPLIER SURVIVE A CUSTOMER AUDIT?" I supported second- and third-party on-site audits — first-meeting preparation, answering questions on site, supplying documents on demand. Then I wrote the corrective action plan for every non-conformity and followed it to closure. I have sat on the side of the table where the answers are given, not asked. "WHAT DOES A RISK ANALYSIS ACTUALLY CONTAIN?" I contributed to product hazard analysis reports covering raw material characteristics, potential hazard identification and process risk control — the documents that later supported raw material acceptance and external audits. Not a template. The real thing. "ALLERGENS — HOW SERIOUSLY IS IT TAKEN?" I handled identification and classification of allergens in raw materials and monitored strict separation of allergen and non-allergen materials to reduce cross-contamination risk. If your product carries an allergen claim, this is one of the first things I would check at a supplier. "CAN THEY PROVE WHERE A BATCH WENT?" I took part in a simulated product recall, verifying traceability across the whole chain from raw material to finished goods sold. Traceability is easy to claim and hard to demonstrate — and it is the first thing that fails under pressure.